FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
134113–134136 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 30, 1988
MODEL #716 ADULT STIM. PADS LOW IMPEDANCE GEL TYPE
K882338 · DRO
Cardiotronics, Inc.
Cardiovascular · 85d
Cleared Aug 30, 1988
HARMAC EXTENSION INFUSION SET
K882347 · FPA
Harmac Medical Specialties, Inc.
General Hospital · 84d
Cleared Aug 30, 1988
DIGITAL BLOOD PRESSURE MONITOR MODEL HEM-703CP
K882393 · DXN
Omron Electronics, Inc.
Cardiovascular · 81d
Cleared Aug 30, 1988
HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II
K882480 · GGN
International Technidyne Corp.
Hematology · 75d
Cleared Aug 30, 1988
HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II
K882481 · GGN
International Technidyne Corp.
Hematology · 75d
Cleared Aug 30, 1988
ANOTRON(R) INCONTINENCE CONTROL SYSTEM
K882555 · KPN
Biosonics, Inc.
Gastroenterology & Urology · 70d
Cleared Aug 30, 1988
ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST
K882687 · LKT
Gull Laboratories, Inc.
Microbiology · 61d
Cleared Aug 30, 1988
MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX
K882691 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 63d
Cleared Aug 30, 1988
HOUVA-BED
K882722 · FTC
National Biological Corp.
General & Plastic Surgery · 60d
Cleared Aug 30, 1988
L.P.I. LASER DELIVERY SYSTEM
K882738 · GEX
Laser Photonics, Inc.
General & Plastic Surgery · 60d
Cleared Aug 30, 1988
ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES
K882741 · CKG
Nichols Institute Diagnostics
Chemistry · 60d
Cleared Aug 30, 1988
FIAGEN HGH FLUOROIMMUNOASSAY KIT
K882823 · CFL
Cyberfluor, Inc.
Chemistry · 53d
Cleared Aug 30, 1988
DTR ANALYZER
K882913 · JJE
Abbott Laboratories
Chemistry · 49d
Cleared Aug 30, 1988
VISTA INSTRUMENT
K882914 · JJE
Abbott Laboratories
Chemistry · 49d
Cleared Aug 30, 1988
METHENO-STAIN KIT
K883052 · JTS
Scientific Device Laboratory, Inc.
Pathology · 42d
Cleared Aug 30, 1988
DART CARBON DIOXIDE
K883055 · KHS
Coulter Electronics, Inc.
Chemistry · 42d
Cleared Aug 30, 1988
WAKO(TM) AUTOKIT AMYLASE
K883059 · CJA
Wako Chemicals USA, Inc.
Chemistry · 42d
Cleared Aug 30, 1988
FLOSSIE
K883225 · JET
Richard G. Deniro
Dental · 29d
Cleared Aug 30, 1988
SYNTHETIC CAST TAPE
K883294 · LGF
Carapace, Inc.
Orthopedic · 26d
Cleared Aug 30, 1988
MODEL #918 MULTI-PADS
K883375 · DRO
Cardiotronics, Inc.
Cardiovascular · 21d
Cleared Aug 30, 1988
SFRE 199-1 MEDIUM, CATALOG NO. 200-2191
K883451 · KIT
J R Scientific
Pathology · 15d
Cleared Aug 29, 1988
VITALOGRAPH-ALPHA
K873562 · BZG
Vitalograph , Ltd.
Anesthesiology · 362d
Cleared Aug 29, 1988
MULTIPURPOSE DIGITAL GAMMACAMERA, GCA-602A
K881013 · IYX
Toshiba Medical Systems
Radiology · 172d
Cleared Aug 29, 1988
FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT
K881015 · JHI
Pacific Biotech, Inc.
Chemistry · 172d